Fx-5A Safety and Tolerability in Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new drug called Fx-5A, which mimics a part of good cholesterol to help remove bad cholesterol and reduce inflammation. The study involves healthy adults aged 18 and older who are not pregnant. Participants will receive a single dose of Fx-5A and be monitored for safety and effects over time.
Will I have to stop taking my current medications?
Yes, participants must stop taking any supplements or medications for at least 8 weeks before joining the trial, except for oral contraceptives.
What makes the drug Fx-5A unique compared to other treatments?
What data supports the effectiveness of the drug Fx-5A?
The research on polyunsaturated phosphatidyl choline (PPC), a component similar to those in Fx-5A, shows that it helped patients with liver failure recover faster and reduced mortality rates. This suggests that components like those in Fx-5A might have beneficial effects in other conditions as well.56789
Who Is on the Research Team?
Marcelo J Amar, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Are You a Good Fit for This Trial?
Healthy adults over 18, not pregnant, willing to use birth control and avoid other studies. Excludes those with allergies to Fx-5A components, recent blood donors, kidney or liver issues, uncontrolled hypertension, recent investigational drug use or certain medication/supplement intake.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive a single intravenous infusion of Fx-5A and are monitored for 24 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits on day 7 and day 28
What Are the Treatments Tested in This Trial?
Interventions
- Fx-5A
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor